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K Number
K231817
Device Name
AlignerFlow LC
Manufacturer
VOCO GmbH
Date Cleared
2023-12-01

(163 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Retention of aligners e.g. by fabrication of aligner attachments
  • Bonding of lingual retainers
  • Occlusal build-ups
Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the AlignerFlow LC device. It indicates that the device has been found substantially equivalent to predicate devices for its stated indications for use (retention of aligners, bonding of lingual retainers, and occlusal build-ups).

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies. The letter is a regulatory clearance document, not a clinical study report or a technical performance evaluation.

Therefore, I cannot provide the requested table and study details based on the input text.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.